Synera Venipuncture Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

Brief Summary

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Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS

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Detailed Description

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Conditions

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Pain Phlebotomy Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch

Group Type EXPERIMENTAL

Synera (lidocaine 70mg/tetracaine 70mg)

Intervention Type DRUG

All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Arm 2

First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch

Group Type EXPERIMENTAL

Synera (lidocaine 70mg/tetracaine 70mg)

Intervention Type DRUG

All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Interventions

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Synera (lidocaine 70mg/tetracaine 70mg)

All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Intervention Type DRUG

Other Intervention Names

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Synera

Eligibility Criteria

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Inclusion Criteria

* Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
* Is 18 years of age or older.
* Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
* Male or female patients
* Has signed the most recent Patient Informed Consent Form
* Has signed a Patient Authorization Form (HIPPA)

Exclusion Criteria

* Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
* Known sensitivity to any components of test materials (sulphites and adhesives)
* Patients with damaged or broken skin at the designated patch site
* Pregnant or breastfeeding women patients
* Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit
* Previous irradiation to the site of the patch

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No